Developing a strong vendor qualification program is extremely important since these components will eventually end up in finished products. When receiving raw materials, Nelson Laboratories performs vendor qualification in order to approve suppliers of pharmaceutical actives and excipients.
In many cases, three lots are tested to verify that the Certificate of Analysis (COA) provided by the vendor is correct. It is important that our sponsor qualify more than one supplier to provide redundancy and business continuity. Thereafter each lot is tested to verify the USP Identification requirement.
Wet and Analytical Chemistry
Nelson Labs Fairfield offers a wide range of services in wet and analytical chemistry. Our highly trained, expert staff which includes Ph.D and Master’s-level scientists, perform analysis of compendial release testing for raw materials and drug products (e.g. USP, EP, JP, BP) on a daily basis in order to meet specifications.
- Compendial Testing
- Dissolution Testing
- Drug Assay (Active Ingredients and Dosage Forms)
- Excipient Testing
- Wet Chemistry Capabilities